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Current practice and perspectives in CRO oversight for Biostatistics & Data Management services – survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa)

Autor: Hennig, M, Knoerzer, D, Schüler, A, Hundt, F, Ruppert, T

Publikováno v: 63. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS); 20180902-20180906; Osnabrück; DOCAbstr. 54 /20180827/

Introduction: Outsourcing of activities is common and increasing in the pharmaceutical industry, not only for clinical trial conduct, or other trial related aspects but also for biostatistics and data management. This raises the question of whether a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9613bd21ee928c2a9bc4245b4ad8b6eb

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Akademický článek

Effects of combined therapy of clopidogrel and aspirin in preventing thrombus formation on mechanical heart valves in an ex vivo rabbit model

Autor: Schlitt, A ^*, Hauroeder, B, Buerke, M, Peetz, D, Victor, A, Hundt, F, Bickel, C, Meyer, J, Rupprecht, H.J

Publikováno v: In Thrombosis Research 2002 107(1):39-43

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Aspekte schutzbedürftiger Patienten sowie der Einwilligung nach Aufklärung in klinischen Prüfungen

Autor: Kuthning, M, Hundt, F

Publikováno v: GMS German Medical Science
GMS German Medical Science; VOL: 11; DOC03 /20130121/

Scope: To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. Methods: Scientific literature search via PubMed, Medline, Google. Results: Voluntary informed consent is

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ddcc3cd190d07a24cc4ee555103962aa
https://pubmed.ncbi.nlm.nih.gov/23346043

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Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in Germany

Autor: Ruppert, T, Hahn, M, Hundt, F

Publikováno v: GMS German Medical Science
GMS German Medical Science, Vol 10, p Doc04 (2012)
GMS German Medical Science; VOL: 10; DOC04 /20120207/

In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with res

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e81d8757a7307d7cbe064cb23cea9fed
https://pubmed.ncbi.nlm.nih.gov/22355280

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Results of a quality control on non-interventional studies

Autor: Wörz, K, Hundt, F

Publikováno v: GMS German Medical Science, Vol 9, p Doc21 (2011)
GMS German Medical Science
GMS German Medical Science; VOL: 9; DOC21 /20110815/

Non-interventional studies (NIS) have for decades been an established part of post-authorisation medicinal research. As early as the mid-nineties, there were at least rudimentary demands for controllable data quality. Beginning with the recommendatio

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::14f29bb38e8e818f6389ca72f420cc7b
http://www.egms.de/en/journals/gms/2011-9/000144.shtml

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Results of a survey on applied quality standards in non-interventional studies among the members of the German Association of Research-based Pharmaceutical Companies

Autor: Hahn, M, Ruppert, T, Bethke, TH, Hundt, F

Publikováno v: GMS German Medical Science
GMS German Medical Science, Vol 8, p Doc29 (2010)
GMS German Medical Science; VOL: 8; DOC29 /20101027/

After the regulatory approval has been obtained, epidemiological studies are acknowledged scientific medical research methods for a new drug which provide additional knowledge about routine application of the drug in clinical daily routine. These stu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bc2ff25ca1f5fd16f3a980f186f3d20e
http://europepmc.org/articles/PMC2975258

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